CN110191732A - Medicament delivery device - Google Patents
Medicament delivery device Download PDFInfo
- Publication number
- CN110191732A CN110191732A CN201880007658.1A CN201880007658A CN110191732A CN 110191732 A CN110191732 A CN 110191732A CN 201880007658 A CN201880007658 A CN 201880007658A CN 110191732 A CN110191732 A CN 110191732A
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- China
- Prior art keywords
- delivery device
- medicament delivery
- stiff case
- deformable
- medicine container
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-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M5/2046—Media being expelled from injector by gas generation, e.g. explosive charge
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/14586—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
- A61M5/1483—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags using flexible bags externally pressurised by fluid pressure
- A61M5/1486—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags using flexible bags externally pressurised by fluid pressure the bags being substantially completely surrounded by fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/155—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by gas introduced into the reservoir
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/587—Lighting arrangements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8218—Gas operated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8218—Gas operated
- A61M2205/8225—Gas operated using incorporated gas cartridges for the driving gas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8237—Charging means
- A61M2205/825—Charging means using mechanical generation of electricity, e.g. hand cranked generators
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Dermatology (AREA)
- Physics & Mathematics (AREA)
- Fluid Mechanics (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
It is a kind of for conveying the medicament delivery device of liquid preparation, comprising: the stiff case comprising deformable medicine container, the deformable medicine container be arranged to accommodate liquid preparation；Gas-pressurized cylinder is connected to stiff case via air valve；Wherein, air valve is releasable, to allow gas to flow into stiff case, is increased so as to cause the gas pressure in stiff case, so that variable compression shape medicine container is with displacement liquid preparation.
Description
Technical field
The present invention relates to a kind of for conveying the device of medicament to patient.
Background technique
In the presence of the various diseases for needing to carry out conventional therapy by injection medicament, and this injection can be by using injection
Device carries out.Various injection devices for conveying medicament injection are well known in the art.Another kind obtains tractive force
Syringe pump is bolus syringe device.Some bolus syringe devices are intended to be used together with relatively great amount of medicament, usually extremely
Lack 1ml and may be a few ml.The so a large amount of medicament of injection may need even a few houres a few minutes.This high capacity is injected
Injection device can be described as Large Copacity device (LVD).In general, these devices are operated by patient oneself, although they can also be by curing
Business personnel operation.
In order to use injection device such as LVD, it is supported on the appropriate injection position on patient skin first.Installation
Afterwards, patient or other people (users) start to inject.In general, realizing starting by user's operation electric switch, this to control
Device operating device.Operation includes that needle is injected into user's body first, is then injected a medicament into the tissue of user.It is getting over
Biological agent is developed more, it includes more highly viscous injectable liquids and with the body bigger than known liquid preparation
Product application.LVD for applying such biological agent may include pre-filled disposable medicament delivery device, or optionally,
Patient or medical worker are using the preceding disposable medicament delivery device that must be inserted drug cartridge.
Some medicament delivery devices promote liquid preparation using plug and plunger in injection process, but these plugs
It may be introduced due to friction and during injection with plunger inefficient.In addition, in these injection devices with plug and plunger
In, due to manufacturing tolerance, there may be dead volumes in medicine container or syringe, this is even after being fully advanced plug
It may cause left drug.
In the LVD of some patients operation, medicament transmission process from start to end may be very long process, and
Sometimes patient is difficult to determine whether injection process is completed.Some medicament delivery devices are provided with airborne equipment, including light source and refer to
Show device system, is used to indicate the pharmaceutical quantities being currently contained in device.In some devices with mobile unit, battery is provided
So as to be mobile unit power supply.However, these devices are usually for storing the relatively long time before conveying medicament.Problem exists
During this storage, it may occur however that battery corrosion and leakage.
Summary of the invention
According to an aspect of the invention, there is provided a kind of for conveying the medicament delivery device of liquid preparation, comprising: packet
Stiff case containing deformable medicine container, the deformable medicine container are arranged to accommodate liquid preparation；Gas-pressurized cylinder, warp
Stiff case is connected to by air valve；Wherein, air valve is releasable, to allow gas to flow into stiff case, so as to cause rigidity
Gas pressure in shell increases, so that variable compression shape medicine container is with displacement liquid preparation.
Medicament delivery device may also include the overflow reservoir that stiff case is connected to via safety valve, wherein safety valve quilt
It is configured to allow gas to flow into overflow reservoir when the gas pressure in stiff case is more than predetermined threshold.
Medicament delivery device may also include the flow quantity detection mechanism in overflow reservoir.
Flow quantity detection mechanism may include the rotating member being arranged in overflow reservoir, and wherein rotating member is configured to lead to
Cross the flow rotation in overflow reservoir.
Rotating member may include multiple blades.
Rotating member may be coupled to indicator system.
Indicator system can include: the transparent window on shell；Indicating element is arranged on rotating member, so that
When rotating member rotation, the outer end of indicating element is moved along transparent window.
Rotating member may be coupled to energy generation apparatus.
Energy generation apparatus may include generator.
Medicament delivery device may also include light source, which, which is arranged to, provides power by energy generation apparatus.
Deformable medicine container can export with communication and be connected to needle injecting systems via fluid path.
Medicament delivery device can be bolus syringe.
Deformable medicine container may include liquid preparation.
According to another aspect of the present invention, a kind of method for operating medical delivery device, the medical transport dress are provided
It sets including stiff case, the stiff case includes deformable medicine container and gas-pressurized cylinder, the deformable medicine container
It is arranged to accommodate liquid preparation, the gas-pressurized cylinder is connected to the stiff case via air valve, this method comprises: release gas
Valve is to allow gas to flow into stiff case, to cause the gas pressure in stiff case to increase, so that variable compression shape medicament holds
Device is with displacement liquid preparation.
Medical delivery device may also include the overflow reservoir that stiff case is connected to via safety valve, and this method is also
It may include that the movement of the air-flow in overflow reservoir is converted into being used to make the torque that the rotating member in overflow reservoir rotates.
With reference to the embodiments described below, these and other aspects of the invention will become obvious and be illustrated.
Detailed description of the invention
Exemplary embodiment of the present invention has been described with reference to the drawings, in which:
Fig. 1 is the schematic diagram of the medicament delivery device according to first embodiment in original state；
Fig. 2 is the schematic diagram of the medicament delivery device according to first embodiment in end-state；
Fig. 3 A is the schematic diagram of a part of the medicament delivery device according to the second embodiment in first state；
Fig. 3 B is the schematic diagram of a part of the medicament delivery device according to the second embodiment for being in the second state；And
Fig. 4 is the schematic diagram of medicament delivery device according to the third embodiment.
Now with detailed reference to embodiment, its example is shown in the drawings, wherein identical appended drawing reference always shows phase
Same element.
Specific embodiment
It provides a kind of for conveying the medicament delivery device of liquid preparation.Medicament delivery device includes containing deformable medicine
The stiff case of agent container, deformable medicine container are arranged to accommodate liquid preparation；Gas-pressurized cylinder, is connected to via air valve
Stiff case；Wherein, air valve is releasable, to allow gas to flow into stiff case, so as to cause the gas in stiff case
Pressure increase, so that variable compression shape medicine container is with displacement liquid preparation.
Medicament delivery device as described above avoids friction relevant to plug and plunger.In addition, dead volume is fairly small,
Because the volume in deformable medicine container can actually be reduced to zero, and in traditional injection arrangement, though due to
Manufacturing tolerance and be fully advanced after plug, be also typically present some residual medicaments.
Medicament delivery device as described herein can be configured to inject a medicament into patient's body.For example, conveying can be with
It is subcutaneous, intramuscular or intravenous.This device can be operated by patient or nursing staff (such as nurse or doctor), and can
To include various types of safety injectors, pen-type injector or automatic injector.The device may include the system based on cylinder,
It is needed using the preceding ampoule for piercing through sealing.It can be about 0.5ml to about with the bolus volume that these different devices convey
2ml.Another device may include Large Copacity device (" LVD ") or patch pump, be configured to adhere to one section of patient skin
Time, (for example, about 5 minutes, 15 minutes, 30 minutes, 60 minutes or 120 minutes) were with conveying " largely " medicament " (normally about 2ml
To about 10ml).
In conjunction with particular agent, presently described device can also be customized, to operate in desired specification.For example, can
With customize the device in special time period injection medicament (for example, be about 3 seconds to about 20 seconds for automatic injector, for
LVD is about 10 minutes to about 60 minutes).Other specifications may include low or floor level discomfort, or with human factor, guarantee the quality
Relevant certain conditions such as phase, validity period, biocompatibility, environmental factor.These variations may be generated due to various factors,
Such as, the range of viscosities of medicament is about 3cP to about 50cP.Therefore, medicament delivery device is generally included having a size of from about 25
To the hollow needle of about 31 capacity specifications.Common-size is 27 capacity specifications and 29 capacity specifications.
Conveying device described herein may also include one or more automatic functions.For example, needle insertion, medicament injection and needle
One or more of withdrawal can be automation.Energy for one or more automation steps can be by one or more
A energy provides.The energy may include for example mechanical, pneumatic, chemistry or electric energy.For example, source of mechanical energy may include spring, lever, bullet
Property body or other mechanical mechanisms to store or release energy.One or more energy can be combined into single device.These
Device may also include gear, valve or other mechanisms, to convert the energy into the movement of one or more components of device.
Some conveying devices may include the one or more functions of safety injector, pen-type injector or automatic injector.
For example, conveying device may include source of mechanical energy and dosing mechanism (as usually found in pen-type injector), the machinery
The energy is configured to automatic injection medicament (as usually found in automatic injector).
Fig. 1 is the schematic diagram of the medicament delivery device according to first embodiment in original state.Below in large capacity
The device is described under the background of device (LVD), but it is to be understood that it can be alternatively another type of bolus infusion
Device.
Medicament delivery device 10 according to a first embodiment of the present invention is shown in Fig. 1.Medicament delivery device 10 can be
Fixed device or mancarried device.Medicament delivery device 10 includes shell 11, and shell 11 includes to be connected to pressurization via air valve 15
The stiff case 12 of gas cartridge 14.Stiff case 12 can be made of metal or duroplasts, and it is to be understood that stiff case can
It is made with the other materials of the rigidity needed for offer stiff case 12.
Gas-pressurized cylinder 14 in the embodiment has the volume of 5ml and includes the nitrogen to pressurize under 1,000Pa.This
Air valve 15 in embodiment is controlled by actuator (not shown in figure 1).When actuator is activated, air valve 15 is arranged to release
To allow gas to flow into stiff case 12 from gas-pressurized cylinder 14.In this embodiment, air valve 15 is only to allow gas along one
The check valve that a direction is flowed through flows to stiff case 12 from gas-pressurized cylinder 14.
Stiff case 12 includes deformable medicine container 13, is filled with liquid preparation in the initial state.Deformable medicine
Agent container 13 can be made of plastics, such as polyvinyl chloride (PVC) or polyethylene.In the present embodiment, deformable medicine container
13 are mounted on the side opposite with the outlet of medicine container 13 of stiff case 12, to ensure the accurate of deformable medicine container 13
It folds.Specifically, as shown in this embodiment, stiff case 12 has elongated shape, and deformable medicine container 13 is maintained at
At the front end of the exit region of medicine container 13, at the front end, be sealed against stiff case 12 and with medicine container
At the opposite rear end in 13 outlet.In the initial state, the deformable medicine container 13 with liquid preparation is substantially filled with just
The entire volume of property shell 12.
Deformable medicine container 13 includes outlet, and medicament can be shifted by the outlet.The outlet of deformable medicine container 13
Needle injecting systems 19 are connected to via fluid path 18.In other words, one end of fluid path 18 is connected to medicine container 13
Outlet, and the other end of fluid path 18 is connected to needle injecting systems 19.Needle injecting systems 19 are connected to needle injecting systems 19.Needle
Injecting systems 19 include hollow injection needle 21, and when deformable medicine container 13 is compressed, medicament can pass through the hollow injection needle 21
Displacement.
Stiff case 12 can be filled by gas, so that deformable medicine container 13 shifts, thus including making liquid preparation
Portion's displacement.Therefore, when air valve 15 is discharged to allow gas to flow into stiff case 12, increased gas pressure is in deformable medicament
Apply compressing force on container 13, is contained in liquid preparation therein will pass through its outlet discharge.
Medicament delivery device 10 further includes overflow reservoir 16.Overflow reservoir 16 is connected to rigid crust via safety valve 17
Body 12.Safety valve 17 is constructed such that safety valve 17 discharges when the gas pressure in proper stiff case 12 is more than predetermined threshold,
To allow gas to flow into overflow reservoir.Therefore, by preventing the intracorporal gas pressure of rigid crust from reaching the high-caliber of danger
Situation, it can be ensured that safety.In this embodiment, safety valve 17 is pressure reducing valve (PRV), is set as pressing in scheduled setting
It is opened under power, to protect stiff case 12 from the pressure more than its design limit.
Fig. 2 is the schematic diagram of the medicament delivery device according to first embodiment in end-state.
When the actuator for being arranged to control air valve 15 is activated to allow gas from the gas-pressurized cylinder in stiff case 12
When 14 flowing, medicament delivery device 10 as shown in Figure 2 is in end-state.In which final state, by being filled out completely with gas
Stiff case 12 is filled, the entire contents of deformable medicine container 13 can be squeezed out from outlet, thus variable compression shape completely
Medicine container 13.
Due to the rigidity of stiff case 12, when gas flows into stiff case 12 from gas-pressurized cylinder 14, increased gas
Pressure applies compressing force on the deformable medicine container 13 being arranged in stiff case 12 with variable compression shape medicine container 13.
Liquid preparation in deformable medicine container 13 is contained in export by it, via fluid path and the displacement of needle injecting systems 19 with
It is injected into injection site.
Once all the elements object in deformable medicine container 13 is shifted, the gas pressure in outer rigid housing 12 will be by
It is continued growing in the continuous flow from gas-pressurized cylinder 14.The threshold when the gas pressure in outer rigid housing is more than predetermined value
Value, safety valve 17 allow gas to flow into overflow reservoir 16 for discharging.Air-flow from stiff case 12 leads to stiff case
Gas pressure in 12 reduces and therefore can prevent from damaging stiff case 12 due to hyperbar.
Fig. 3 A is the schematic diagram of a part of the medicament delivery device according to the second embodiment in first state, and
Fig. 3 B is the schematic diagram of a part of the medicament delivery device according to the second embodiment for being in the second state.Specifically, Fig. 3 A
With Fig. 3 B respectively illustrate complete injection process (that is, first state) before and complete injection process (that is, second state) it
A part of the overflow reservoir 26 of medicament delivery device afterwards.
The medicament delivery device of second embodiment is similar to the medicament delivery device 10 of first embodiment, wherein being added to cloth
The rotating member 22 in overflow reservoir 16 is set, rotating member 22 is connected to the finger including indicating element and transparent window 24
Show device system.Transparent window 24 in the embodiment is located at shell 11, to allow user to determine the direction of indicating element.
In this embodiment, rotating member 22 is considered as flow quantity detection mechanism.Rotating member 22 is arranged in overflow storage
In device 16, and it is especially structured to when gas flows into overflow reservoir 16 from stiff case 12 along single direction (as schemed
Shown in 3A and Fig. 3 B clockwise) rotation.In other words, the air motion in overflow reservoir 16 is converted into for making to revolve
Turn the torque of the rotation of component 22.
In this embodiment, the indicating element 23 of indicator system is long and narrow component, is arranged in rotating member 22
Surface at so that its extending centrally out from rotating member 22.Indicating element 23 is fixedly attached to rotating member 22,
So that the outer end of indicating element 23 is moved to second from first position along transparent window 24 when rotating member 22 rotates
It sets.First position corresponds to the first state that injection process does not complete, and the second position corresponds to that injection process is completed
Two-state.
When the first end of transparent window 24 indicates deformable 13 non-empty of medicine container, the second end expression of transparent window 24 can
Deform when medicine container 13 is empty.Therefore, when the outer end of indicating element 23 is moved to along transparent window 24 from one end
When the other end, user can determine that injection process is completed.
When actuator (not shown) is activated to discharge air valve 15, stiff case 12 is gradually filled with gas, therefore
Gas pressure in stiff case 12 continues growing.The increased gas pressure applies compression on deformable medicine container 13
Power, will pass through the liquid preparation that its outlet discharge is included in.
Once all the elements object in deformable medicine container 13 is shifted, the gas pressure in outer rigid housing 12 will be by
It is continued growing in the continuous flow from gas-pressurized cylinder 14.When the gas pressure in outer rigid housing is more than predetermined value in threshold
When value, safety valve 17 allows gas to flow into overflow reservoir 16 for discharging.
The gas for flowing into overflow reservoir 16 causes rotating member 22 to rotate along single direction, this makes indicating element 23 again
Outer end along transparent window 24 from the inswept other end in one end.This shows in Fig. 3 A and Fig. 3 B, and indicator structure is shown respectively
The outer end of part 23 is in first position (Fig. 3 A) and the second position (Fig. 3 B).Therefore, when the outer end of indicating element 23 is along saturating
When bright window 24 is moved to the other end from one end, user can determine when deformable medicine container 13 is empty and when leads to
The direction of check indicator component 23 is crossed to complete injection process.
Fig. 4 is the schematic diagram of a part of medicament delivery device according to the third embodiment.
The medicament delivery device of 3rd embodiment is similar to the medicament delivery device of first embodiment, increases rotating member
22, pinion gear (being not shown in Fig. 4), worm gear 25, worm screw 26, energy generation apparatus 27 and light source 28.
In this embodiment, rotating member 22 is considered as a part of flow quantity detection mechanism.Rotating member 22 is arranged in
In overflow reservoir 16 and it is especially structured to individually rotate when gas flows into overflow reservoir 16 from stiff case 12.
In other words, the movement of the air-flow in overflow reservoir 16 is converted into the torque for rotating rotating member 22.
As shown in figure 4, in this embodiment, rotating member 22 includes multiple blades and is fixedly attached to pinion gear
(being not shown in Fig. 4), pinion gear are configured to engage with worm gear 25.In this embodiment, worm gear 25, which is formed, has worm screw
26 worm drive arrangement.Specifically, worm gear 25 includes multiple teeth, these teeth and the screw thread on the outer surface of worm screw 26
Arrangement engagement.In worm drive arrangement, rotary motion is transmitted through 90 ° of angles.In other words, worm gear 25 is in first axle
Rotary motion cause rotary motion of the worm screw 26 on the second axis, first axle is perpendicular to the second axis.
Worm screw 26 is mechanically connected to energy generation apparatus 27.In this embodiment, energy generation apparatus 27 includes power generation
Machine, the generator are configured to machinery being converted into DC current.
Although being not shown, energy generation apparatus 27 is electrically connected to light source 28, in this embodiment light source 28
It is light bulb.Therefore, when energy generation apparatus 27 converts the mechanical rotation of worm screw 26, light source 28 is powered.
When actuator (not shown) is activated to discharge air valve 15, stiff case 12 is gradually filled with gas, and
Therefore the gas pressure in stiff case 12 continues growing.The increased gas pressure applies pressure on deformable medicine container 13
Contracting power, will pass through the liquid preparation that its outlet discharge is included in.
Once all the elements object in deformable medicine container 13, by displacement, the gas pressure in outer rigid housing 12 will
It is continued growing due to the continuous flow from gas-pressurized cylinder 14.When the gas pressure in outer rigid housing is more than predetermined threshold
When, safety valve 17 allows gas to flow into overflow reservoir 16 for discharging.
The gas for flowing into overflow reservoir 16 causes rotating member 22 to rotate along single direction.Due to rotating member 22 and small
Attachment between gear (being not shown in Fig. 4), pinion gear are rotated and are engaged with worm gear 25, worm gear 25 together with rotating member 22
It is engaged again with worm screw 26, to be transmitted through the rotary motion at 90 ° of angles.When worm screw 26 rotates, connected by worm screw 26
The energy generation apparatus 27 being connected to generates electric current.In the present embodiment, the energy of the generation is used to power for light source 31.Therefore,
Light source 31 may be used to indicate injection process and be completed.
In alternative embodiments, medicament delivery device can be pen-type injector rather than bolus syringe.
In alternative embodiments, energy generation apparatus may be electrically connected to energy storage device, such as capacitor, rather than
It is directly connected to light source.In these alternate embodiments, the energy (DC current) generated at energy generation apparatus can be deposited
Storage in energy storage devices, and can power for subsequent use in for the mobile unit at device.
In alternative embodiments, deformable medicine container can be made of other materials, these materials will allow medicament to hold
Device is compressed and/or is folded under gas pressure.
In alternative embodiments, the air valve that gas-pressurized cylinder is connected with stiff case can be by the different elements control in device
System.For example, air valve can be controlled by control device (for example, dial), enter just to control and adjust from gas-pressurized cylinder
The gas flow rate of property shell.Moreover, in alternative embodiments, other kinds of valve can be used (for example, diaphragm valve, pinch valve
Deng) replace check valve as air valve.
In alternative embodiments, other kinds of gas (such as air, carbon dioxide, oxygen etc.) can be used and be used as and add
Press the gas for including in gas cartridge rather than nitrogen.It include that gas in gas-pressurized cylinder can moreover, in alternative embodiments
With different gas pressure value pressurizations.
In alternative embodiments, the size and/or size of gas-pressurized cylinder can be adjusted according to design requirement.
In alternative embodiments, the safety valve that overflow reservoir is connected with stiff case can be pressure safety valve (PSV)
Rather than pressure relief valve (PRV).Moreover, in alternative embodiments, other kinds of valve can be used as safety valve, without
It is pressure reducing valve.
In alternative embodiments, rotating member can be by the other kinds of flow quantity detection mechanism generation in overflow reservoir
It replaces.In these alternate embodiments, flow quantity detection mechanism may include at least one of the following: Archimedian screw component surpasses
Acoustic detector, electromagnetic transmission detection device.Moreover, flow quantity detection mechanism may be coupled in these alternate embodiments
Indicator system or energy generation apparatus.For example, in the substitution with the flow quantity detection mechanism including Archimedian screw component
In embodiment, Archimedian screw component can be mechanically connected to energy generation apparatus, so as to when Archimedian screw component due to
Air-flow in overflow reservoir and while rotating, generate direct current.
In alternative embodiments, the scale of indicating element and indicator system can use other shapes and construction.Example
Such as, indicating element in alternative embodiments can be arranged on the fan-shaped component at the surface of rotating member so that its from
Rotating member extends centrally out, and scale can be arranged on the flat covering member on the top of indicating element
Arcuate socket.Indicating element can be fixedly attached to rotating member, so that when rotating member rotation, indicating element rotation
To cover arcuate socket (that is, scale).In other alternate embodiments, linear graduation can be alternatively used.
Although claim to be formulated as to the specific combination of feature in this application, but it is to be understood that this public affairs
The range opened further includes any novel combination of any novel feature disclosed herein or feature, regardless of whether explicitly or implicitly or
Any summary, regardless of whether the present invention relates to the claimed identical invention in any claim at present, and nothing
Any or all identical technical problem same as the present invention whether is alleviated by it.Applicant notifies herein, in the application
Or thus derived from any course of the review further applied, new right can be formulated to these features and/or feature combination
It is required that.
It will be understood by those skilled in the art that in the case where not departing from full scope and spirit of the invention, it can be to this
Substance described in text, preparation, device, method, the various components of system and embodiment modify (addition and/or removal),
Including these modifications and its any and all equivalents.
Term " drug (drug) " or " medicament (medicament) " synonymous use herein, and describe containing one
Kind or various active drug ingedient or its pharmaceutically acceptable salt or solvate and optional pharmaceutically acceptable load
The pharmaceutical preparation of body.In a broad sense, active pharmaceutical ingredient (" API ") is the chemical structure for having biological effect to human or animal.
In pharmacology, drug or medicament are for treating, curing, preventing or diagnosing the illness or for otherwise enhancing body or essence
Refreshing health.Drug or medicament can be used for the limited duration, or be regularly used for chronic disease.
As described below, drug or medicament may include it is at least one for treat one or more diseases in several formulations
In API or combinations thereof.Illustrative API may include the small molecule with 500Da or smaller molecular weight；Polypeptide；Peptide and egg
White (such as hormone, growth factor, antibody, antibody fragment and enzyme)；Sugar and polysaccharide；And nucleic acid, double-strand or single stranded DNA are (including naked
And cDNA), RNA, antisense nucleic acid such as antisense DNA and RNA, siRNA (siRNA), ribozyme, gene and oligonucleotides.Nucleic acid
It may be incorporated into molecule delivery system such as carrier, plasmid or liposome.Also cover the mixture of these one or more drugs.
Term " medicine delivery device " should be any in human or animal's body comprising being configured to for drug or medicament being assigned to
The device or system of type.Without restrictive, medicine delivery device can be injection device (for example, injection tube, pen type are infused
Emitter, self-service syringe, high volume settings, pump, perfusion system are configured for intraocular, subcutaneous, muscle or intravascular
Conveying other devices), dermal patch (for example, permeability chemicals microneedle), inhalator (for example, be used for nose or lung
), implantable device (for example, drug or API coating bracket, capsule) or the feed system for gastrointestinal tract.It is described here
Drug to combine include the injection device of needle (for example, hypodermic needle with No. 24 or bigger gauges) may be special
Useful.
Drug or medicament can be contained in the primary package or " drug container " for being suitable for that medicine delivery device is combined to use
It is interior.Drug container can be such as cylindrantherae, injection tube, memory or be configured to storage (for example, short-term or long-term storage)
More than one drugs provide the other solids or flexible container of chamber appropriate.For example, in some cases, chamber can be set
Count into drug at least one day (for example, 1 day at least 30 days) of storage.In some cases, chamber can be designed to store medicine
Object about 1 month to about 2 years.Storage can indoors temperature (for example, about 20 DEG C) or cryogenic temperature (for example, from about -4 DEG C to about 4
DEG C) under carry out.In some cases, drug container can be two-chamber chamber cartridge or may include two-chamber chamber cartridge, the two-chamber
Chamber cartridge be configured to independently to store Pharmaceutical formulation to be fed two or more ingredients (for example, API and diluent, or
Two distinct types of drug), a kind of each ingredient of chamber.In this case, the two chambers of two-chamber chamber cartridge can be with
It is configured to allow between drug or the two or more ingredients of medicament before being assigned in human or animal's body and/or is being assigned to
It is mixed during in human or animal's body.For example, two chambers can be constructed such that they be in fluid communication with each other (for example,
By the conduit between two chambers) and allow to mix two kinds of ingredients when user needs before a distribution.As substitution
Mode, or in addition, two chambers can be configured to allow for mixing when these ingredients are just being assigned in human or animal's body
It closes.
Drug included in medicine delivery device as described herein or medicament can be used for treating and/or preventing it is a variety of not
The illness of same type.Illustrative illness includes such as diabetes or complication such as diabetic retinal relevant to diabetes
Lesion, thromboembolic disorders such as Deep venou or pulmonary thromboembolism.Other examples of illness are acute coronary syndrome
(ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, pollinosis, atherosclerosis and/or rheumatoid joint
It is scorching.The example of API and drug be described in the handbook such as Rote Liste 2014 those, such as, but not limited to, main group
12 (antidiabetic medicines) or 86 (tumour medicines) and Merck Index, the 15th edition.
The example of API for treating and/or preventing 1 type or diabetes B or complication relevant to diabetes includes
Insulin, such as actrapid monotard or human insulin analogue or derivative, glucagon-like peptide (GLP-1), GLP-1 analog
Or GLP-1 receptor stimulating agent or its analog or derivative, dipeptidyl peptidase-4 (DPP4) inhibitor or its is pharmaceutically acceptable
Salt or solvate or its any mixture.As used herein term " analog " and " derivative " refer in structure and
Original matter is similar enough to have the function of any substance of essentially similar or activity (such as therapeutic efficiency).Particularly,
Term " analog " refers to the polypeptide with molecular structure, can be derived from the structure of naturally occurring peptide in form, such as
The structure of actrapid monotard, by lacking and/or exchanging at least one amino acid residue and/or by adding at least one amino acid
Residue.Addition and/or exchange amino acid residue can be the amino acid residue or other naturally occurring residues of codified
Or it is homozygous at amino acid residue.Insulin analog is also referred to as " insulin receptor ligand ".Particularly, term " derivative " is
Refer to the polypeptide with the molecular structure that can be derived from naturally occurring peptide (for example, structure of actrapid monotard) in form, wherein
One or more organic substituents (for example, fatty acid) is in conjunction with one or more amino acid.Optionally, naturally occurring peptide
Present in one or more amino acid may be deleted and/or by other amino acid substitutions, the amino including not codified
Acid or amino acid have added to naturally occurring peptide including not codified.
The example of insulin analog is Gly (A21), Arg (B31), Arg (B32) actrapid monotard's (insulin glargine)；
Lys (B3), Glu (B29) actrapid monotard's (glulisine)；Lys (B28), Pro (B29) actrapid monotard's (insulin lispro)；
Asp (B28) actrapid monotard；Actrapid monotard, wherein the proline at the B28 of position replace with Asp, Lys, Leu, Val or Ala and its
Lys at middle position B29 replaces with Pro；Ala (B26) actrapid monotard；Des (B28-B30) actrapid monotard；Des (B27) people's pancreas
Island element and Des (B30) actrapid monotard.
The example of insulin derivates is such as B29-N- myristoyl-Des (B30) actrapid monotard；Lys (B29) (N- ten
Four acyls)-Des (B30) actrapid monotard；B29-N- palmityl-Des (B30) actrapid monotard；B29-N- palmitoyl human insulin；
B28-N- myristoyl Lispro；B28-N- palmityl-Lispro；B30-N- meat
Myristoyl-ThrB29LysB30 actrapid monotard；B30-N- palmityl-ThrB29LysB30 actrapid monotard；B29-N- (N- palm
Acyl-gamma-glutamyl)-Des (B30) actrapid monotard；B29-N- ω-carboxyl pentadecanoyl base-γ-L- glutamyl Des (B30) people
Insulin (moral paddy insulin,)；B29-N- (N- stone gallbladder acyl-gamma-glutamyl)-Des (B30) actrapid monotard；B29-
N- (ω-carboxyl heptadecanoyl)-Des (B30) actrapid monotard and B29-N- (ω-carboxyl heptadecanoyl) actrapid monotard.
The example of GLP-1, GLP-1 analog and GLP-1 receptor stimulating agent is for example: LixisenatideExenatide (Exendin-4) (Exendin-4 (exendin-4)//(passing through the peptide for 39 amino acid that gilamonster salivary gland generates), Liraglutide
Semaglutide (Suo Malu peptide), Taspoglutide (Ta Silutai), A BilutaiDulaglutiderExendin-4、CJC-1134-PC、PB-1023、TTP-054、Langlenatide/HM-11260C、
CM-3、GLP-1Eligen、ORMD-0901、NN-9924、NN-9926、NN-9927、Nodexen、Viador-GLP-1、CVX-
096、ZYOG-1、ZYD-1、GSK-2374697、DA-3091、MAR-701、MAR709、ZP-2929、ZP-3022、TT-401、
BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN and
Glucagon-Xten。
Oligonucleotides is the raw sodium of such as meter Bo MeiFor treating the drop of familial high cholesterol
The antisense therapy of low cholesterol.
The example of DPP4 inhibitor be Vildagliptin (vildagliptin), Sitagliptin (sitagliptin),
Denagliptin (Na Lieting), Saxagliptin (saxagliptin), Berberine (jamaicin).
The example of hormone includes pituitrin or hypothalamic hormone or modulability active peptide and its antagonist, such as promotees sexual gland and swashs
Plain (Gonadotropine) (follitropic hormone (Follitropin), metakentrin (Lutropin), human chorionic gonadtropin
(Choriongonadotropin), menotropin (Menotropin)), Somatropine (growth hormone) (somatropin
(Somatropin)), minirin (Desmopressin), terlipressin (Terlipressin), Gonadorelin
(Gonadorelin), Triptorelin (Triptorelin), Leuprorelin (Leuprorelin), Buserelin
(Buserelin), nafarelin (Nafarelin) and Goserelin (Goserelin).
The example of polysaccharide includes glutinous polysaccharide, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or it spreads out
The poly-sulfated form and/or its pharmaceutically acceptable salt of biology or for example above-mentioned polysaccharide of sulfated polysaccharides.Poly-sulfated
The example of the pharmaceutically acceptable salt of low molecular weight heparin is Enoxaparin Sodium (enoxaparin sodium).Hyaluronic acid spreads out
The example of biology is Hylan G-F 20Sodium Hyaluronate.
Terms used herein " antibody " refer to immunoglobulin molecules or its antigen-binding portion thereof.Immunoglobulin molecules are anti-
The example of former bound fraction includes F (ab) and F (ab')2Segment retains the ability for combining antigen.Antibody can be it is polyclonal,
Monoclonal is recombinated, is fitted into, removing immune or humanization, overall length people, inhuman (such as muroid) or single-chain antibody.In some embodiment party
In case, antibody has effector function and can complement-fixing.In some embodiments, antibody does not have or the combination with reduction
The ability of Fc receptor.For example, antibody can be homotype or hypotype, antibody fragment or mutant, the knot with Fc receptor is not supported
It closes, such as its receptor binding domain Fc with mutagenesis or missing.Term antibody further includes immune based on the series connection of tetravalence bispecific
Globulin (TBTI) and/or the dual variable protein-bonded antigen binding of domain antibodies sample with intersection combined area orientation (CODV)
Molecule.
Term " segment " or " antibody fragment " refer to from the more of antibody polypeptides molecule (such as antibody weight and/or light chain polypeptide)
Peptide, not including full length antibody polypeptide but still include at least can be with a part of the full length antibody polypeptide of antigen binding.Antibody
Segment may include the cut portion of full length antibody polypeptide, but term is not limited to the cutting segment.It is effective in the present invention anti-
Body segment includes such as Fab segment, 2 segment of F (ab'), scFv (scFv) segment, linear antibodies, monospecific or mostly special
Property antibody fragment such as bispecific, tri-specific, four specificity and multi-specificity antibody it is (such as double antibody, three antibody, four anti-
Body), unit price or multivalent antibody fragment such as divalent, trivalent, tetravalence and multivalent antibody, miniantibody, chelating recombinant antibody, three function
Can antibody (tribodies) or bifunctional antibody (bibodies), interior antibody, nano antibody, little module immune drug (SMIP),
Binding domain domain-immunoglobulin fusion proteins, hunchbacked source antibody and the antibody containing VHH.Other examples of antigen binding antibody fragment are
It is known in the art.
Term " complementary determining region " or " CDR " refer to the short polypeptide sequence in both heavy chain and light chain polypeptide variable region,
It is mainly responsible for and mediates specific antigen identification.Term " framework region " refers to the amino acid in both heavy chain and light chain polypeptide variable region
Sequence is not CDR sequence, and is mainly responsible for and CDR sequence is maintained to be properly positioned to allow antigen binding.Such as this field
Know, although framework region themselves does not participate in antigen binding directly, some residues in certain antibody framework areas can be participated in directly
Antigen binding or the ability that one or more amino acid and antigen interactions in CDR can be influenced.
The example of antibody be anti-PCSK-9mAb (such as A Liku monoclonal antibody (Alirocumab)), anti-IL-6mAb (such as
) and anti-IL-4mAb (such as Dupilumab) Sarilumab.
It is also possible to consider make in the drug or medicament in drug delivery device for the acceptable salt of any API as described herein
With.Pharmaceutically acceptable salt is such as acid-addition salts and basic salt.
It will be understood to those of skill in the art that can be in the case where not departing from full scope and spirit of the invention, to this
The API of described in the text, formula, equipment, method, system and embodiment each component/component modify (addition and delete),
Full scope and spirit of the invention includes such modification and its any and all equivalents.
Claims (15)
1. a kind of for conveying the medicament delivery device of liquid preparation, comprising:
Outer rigid housing comprising deformable medicine container, the deformable medicine container are arranged to comprising the liquid preparation；
Gas-pressurized cylinder is connected to the stiff case via air valve；
Wherein the air valve is releasable, to allow gas to flow into the stiff case, so as to cause in the stiff case
Gas pressure increase, to compress the deformable medicine container with liquid preparation described in displacement.
2. medicament delivery device according to claim 1 further includes being connected to overflowing for the stiff case via safety valve
Reservoir is flowed, wherein the safety valve is configured to allow gas when the gas pressure in the stiff case is more than predetermined threshold
Body flows into the overflow reservoir.
3. medicament delivery device according to claim 2 further includes the flow quantity detection mechanism in the overflow reservoir.
4. medicament delivery device according to claim 3, wherein the flow quantity detection mechanism includes being arranged in the overflow
Rotating member in reservoir, wherein the rotating member is configured to through the flow rotation in the overflow reservoir.
5. medicament delivery device according to claim 4, wherein the rotating member includes multiple blades.
6. medicament delivery device according to claim 4 or 5, wherein the rotating member is connected to indicator system.
7. medicament delivery device according to claim 6, wherein the instruction system includes:
Transparent window at the shell；With
Indicating element is arranged at the rotating member, so that when rotating member rotation, the indicating element
Outer end moved along the transparent window.
8. medicament delivery device according to claim 4 or 5, wherein the rotating member is connected to energy generation apparatus.
9. medicament delivery device according to claim 8, wherein the energy generation apparatus includes generator.
10. medicament delivery device according to claim 8 or claim 9 further includes light source, the light source is arranged to by the energy
Volume production generating apparatus provides power.
11. medicament delivery device according to any one of the preceding claims, wherein the deformable medicine container with go out
Mouth is in fluid communication, and the outlet is connected to needle injecting systems via fluid path.
12. medicament delivery device according to any one of the preceding claims, wherein the medicament delivery device is to inject
Syringe.
13. injection device according to any one of the preceding claims, wherein the deformable medicine container includes liquid
Medicament.
14. a kind of method for operating medical delivery device, the medical delivery device includes stiff case, the stiff case packet
Containing deformable medicine container and gas-pressurized cylinder, the deformable medicine container is arranged to accommodate liquid preparation, the pressurization gas
Body cylinder is connected to the stiff case via air valve, which comprises
The air valve is discharged to allow gas to flow into the stiff case to cause the gas pressure in the stiff case to increase
Add, to compress the deformable medicine container with liquid preparation described in displacement.
15. according to the method for claim 14, wherein the medical delivery device further includes being connected to institute via safety valve
The overflow reservoir for stating stiff case, the method also includes being converted into being used for by the movement of the air-flow in the overflow reservoir
The torque for rotating the rotating member in the overflow reservoir.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17152921.7 | 2017-01-24 | ||
| EP17152921 | 2017-01-24 | ||
| PCT/EP2018/051375 WO2018138022A1 (en) | 2017-01-24 | 2018-01-22 | Medicament delivery device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN110191732A true CN110191732A (en) | 2019-08-30 |
| CN110191732B CN110191732B (en) | 2023-02-17 |
Family
ID=57890719
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201880007658.1A Active CN110191732B (en) | 2017-01-24 | 2018-01-22 | Medicament delivery device |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US20190366002A1 (en) |
| EP (1) | EP3573686A1 (en) |
| JP (1) | JP7030821B2 (en) |
| CN (1) | CN110191732B (en) |
| WO (1) | WO2018138022A1 (en) |
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| CN115154762A (en) * | 2022-07-27 | 2022-10-11 | 重庆倍加医疗器械有限公司 | Air pressure driven syringe |
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| PT1762259E (en) | 2005-09-12 | 2010-12-10 | Unomedical As | Inserter for an infusion set with a first and second spring units |
| US10194938B2 (en) | 2011-03-14 | 2019-02-05 | UnoMedical, AS | Inserter system with transport protection |
| WO2020045096A1 (en) * | 2018-08-29 | 2020-03-05 | 株式会社村田製作所 | Humidifying device, and humidifying and air delivering device with same for respiratory organs |
| CA3141608A1 (en) | 2019-05-20 | 2020-11-26 | Unomedical A/S | Rotatable infusion device and methods thereof |
| CA3146856A1 (en) * | 2019-07-24 | 2021-01-28 | Enable Injections, Inc. | Medical fluid injection and transfer devices and method |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN110191732B (en) | 2023-02-17 |
| JP2020505145A (en) | 2020-02-20 |
| JP7030821B2 (en) | 2022-03-07 |
| EP3573686A1 (en) | 2019-12-04 |
| WO2018138022A1 (en) | 2018-08-02 |
| US20190366002A1 (en) | 2019-12-05 |
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